Letermovir to Prevent Cytomegalovirus Infection After Stem Cell Transplant in Children and Teens

What this Trial Is About

Researchers are evaluating whether taking letermovir as a preventive treatment can lower the chance of cytomegalovirus CMV infection in children and adolescents undergoing stem cell transplants. This phase III trial focuses on patients aged 2 to 18 years who receive allogeneic hematopoietic cell transplants. CMV infection risk increases after transplant due to weakened immune systems from preparative treatments, and letermovir is an antiviral drug that stops CMV from multiplying to potentially prevent or lessen infection severity. Participants receive letermovir once daily, either by mouth or through an intravenous infusion lasting about 60 minutes, starting the day after transplant and continuing for 14 weeks. Blood samples are collected regularly to test for CMV DNA levels weekly for the first 14 weeks, then every two weeks up to week 24, and at weeks 32, 40, and 52. The study also monitors survival without CMV infection through 24 weeks and tracks other health outcomes such as time to immune recovery, kidney function, and hospital stays. During the study, participants undergo frequent blood tests to detect CMV infection and immune response. Researchers measure clinically significant CMV infections up to 14 weeks post-transplant as the main outcome, with longer-term follow-up to 52 weeks. Other assessments include monitoring adverse events like neutropenia and kidney issues, plus examining viral resistance patterns. The total participation period includes regular visits and testing across about one year to evaluate letermovirs role in preventing CMV infection after transplant.

A Study of the Drug Letermovir as Prevention of Cytomegalovirus Infection After Stem Cell Transplant in Pediatric Patients